CN103917194A

CN103917194A - Transcatheter valve prosthesis

Info

Publication number: CN103917194A
Application number: CN201280054486.6A
Authority: CN
Inventors: 格奥尔格·柏特琳; 马雷克·纳斯尔
Original assignee: Highlife SAS
Current assignee: Highlife SAS
Priority date: 2011-09-12
Filing date: 2012-06-13
Publication date: 2014-07-09
Anticipated expiration: 2032-06-13
Also published as: CN103917194B; EP2755602B1; EP2755602A1; AU2012307772A1; CA2848251A1; CA2848251C; WO2013037519A1; US20140214157A1; AU2012307772B2; US9662206B2

Abstract

A transcatheter atrio-ventricular valve prosthesis (1) for functional replacement of an atrio-ventricular heart valve in a connection channel ( 10), having a circumferential connection channel wall structure (25), between the atrial chamber (15) and the ventricular chamber (20) of a heart, comprising a radially expandable tubular body (30) to be disposed in the interior of the connection channel (10) and extending along an axis (35), and a valve (40) arranged within and attached to the tubular body (30), wherein the tubular body (30) is provided with an outer circumferential groove (45) which is open to the radial outside of the tubular body (30) and which defines a groove bottom (46), whereby the tubular body (30) is separated by the outer circumferential groove into first (31) and second (32) body sections, and wherein the tubular body (30); is provided with a first plurality of projections (50, 55) which extend from the first or second body section (31, 32) in an axial direction of the tubular body (30) and each of which has a free end (60, 65) arranged to overlap the outer circumferential groove (45), further comprising an elongate outer member (75) to be disposed at the exterior of the connection channel wall structure (25) at a level of the circumferential grove (45), wherein the outer member (75) can at least partially extend around the tubular body (30) with valve tissue of the connection channel wall structure (25) being correspondingly circumferentially arranged between the tubular body (30) and the outer member (75) and in such a radial distance (R5) to the axis (35) of the tubular body (30) that the valve tissue of the connection channel wall structure (25); can be radially forced into the outer circumferential groove (45) so as to be at least partially located radially below the projections (50, 55).

Description

Through conduit valve prosthesis

Technical field

Embodiment relates generally to through conduit valve prosthesis, relates in particular to through conduit chamber valve prosthesis.

Background technology

Valvular heart disease affects about 300.000 people in the world every year.Those metabasises are abnormal (the excessive tissue growth of lobe leaf texture, tissue deterioration/breaking, the hardening of tissue/calcification) or abnormal (by the tissue location of cardiac cycle, lobe ring extension, Ventricular Remodeling), cause valvular function to be degenerated, such as leakage/blood back flow (valve insufficiency) or blood constricted flow (valvular stenosis) forward.

Therefore be, desirable for valvular replacement of function through conduit valve prosthesis.

Summary of the invention

Various embodiment of the present invention provide a kind of valvular replacement of function of chamber for the interface channel between atrial chamber and the ventricular chamber of heart through conduit chamber valve prosthesis, described interface channel has circumference interface channel wall construction, describedly comprise radially expandable tubular main body through conduit chamber valve prosthesis, described radially expandable tubular main body will be arranged in the inside of described interface channel and along Axis Extension, and valve, described valve is arranged in described tubular body and is attached to described tubular body, wherein said tubular body is with outer circumferential groove, bottom portion of groove is opened wide and limited to described outer circumferential groove to the radial outside of described tubular body, described tubular body is divided into the first and second main part sections by described outer circumferential groove thus, and wherein said tubular body is with more than first projection, described more than first projection extended and each of described more than first projection has and is arranged to the free end overlapping with described outer circumferential groove from the described first or second main part section on the axial direction of described tubular body, also comprise microscler external component, described microscler external component is arranged in the level place at described circumferential groove on the outside of described interface channel wall construction, wherein said external component can extend around described tubular body at least in part, thereby the valvular tissue of described interface channel wall construction is correspondingly arranged between described tubular body and described external component circumferentially and from the described axis of described tubular body have valvular tissue that such radial distance makes described interface channel wall construction can radially be pushed in described outer circumferential groove, be positioned at least in part described projection footpath downwards.

It is a kind of for implanting the method through conduit chamber valve prosthesis that various embodiment of the present invention also provides, describedly comprise tubular body and microscler external component through conduit chamber valve prosthesis, described tubular body has longitudinal axis, circumferential groove and multiple projection, each projection has and is arranged to overlapping with described groove at least in part free end, said method comprising the steps of: the inside that described tubular body is positioned to the interface channel between atrial chamber and the ventricular chamber of heart, described microscler external component is positioned on the outside of described interface channel at the axial level place of described circumferential groove, and by reducing distance between described microscler external component and described tubular body, thereby the tissue of described interface channel is inserted in described groove with respect to described axis at least in part in the inner radial of described projection and with respect to the fixing described prosthese of heart.

Brief description of the drawings

In the accompanying drawings, similar Reference numeral represents generally all the time identical part in different views.Accompanying drawing may not be drawn in proportion, but emphasizes generally to illustrate principle of the present invention.In the following description, various embodiment are described with reference to the following drawings, wherein:

Fig. 1 schematically show be arranged in human heart interface channel according to embodiment through conduit valve prosthesis,

Fig. 1 a shows according to the free-ended details of the projection of the valve prosthesis of modification,

Fig. 1 b shows according to the free-ended details of the projection of the valve prosthesis of modification,

Fig. 2 show according to embodiment through conduit valve prosthesis,

Fig. 2 a schematically shows according to the extension angle of the projection of embodiment,

Fig. 3 schematically show be arranged in human heart interface channel according to embodiment comprise microscler external component through conduit valve prosthesis,

Fig. 4 show according to embodiment comprise clamping element through conduit valve prosthesis,

Fig. 5 from different visual angle displayed map 4 comprise clamping element through conduit valve prosthesis,

Fig. 6 a shows along the schematic cross-section through conduit valve prosthesis of the A-A in Fig. 3,

Fig. 6 b shows along the schematic cross-section through conduit valve prosthesis of the B-B in Fig. 3,

Fig. 6 c shows the schematic cross-section through conduit valve prosthesis along the C-C in Fig. 4 that comprises clamping element,

Fig. 6 d shows the schematic cross-section through conduit valve prosthesis along the D-D in Fig. 4 that comprises clamping element in being different from another layout shown in Fig. 6 c,

Fig. 7 schematically shows the interaction through conduit valve prosthesis, heart tissue and microscler external component according to embodiment,

Fig. 8 show according to embodiment through conduit valve prosthesis,

Fig. 9 shows the tubular body through conduit valve prosthesis,

Figure 10 schematically show comprise external component through conduit valve prosthesis, and

Figure 11 schematically show according to modification comprise microscler external component through conduit valve prosthesis.

Detailed description of the invention

Below describe in detail with reference to accompanying drawing, accompanying drawing is shown and can be implemented detail of the present invention and embodiment by example.Enough describe these embodiment in detail to enable those skilled in the art to implement the present invention.Can use other embodiment and can carry out structure, logic and electric variation and not depart from the scope of the present invention.Various embodiment need not to be mutual repulsion, and reason is that some embodiment can combine to form new embodiment with one or more other embodiment.

With reference to figure 1,1a, 1b and 2, can comprise tubular body 30 through conduit chamber valve prosthesis, the described interface channel connection atrium chambers of the heart 15 and ventricular chamber 20 and comprise interface channel wall construction 25 for the replacement of function of (nature) chamber cardiac valve 5 of interface channel 10.Tubular body 30 can be arranged in the inside of interface channel 10 and extend along axis 35.Axis 35 can be can be the longitudinal axis 35 of the tubular body 30 of elongate body.Under implanting state, the axis 35 of tubular body 30 can with roughly coaxial alignment of the axis of interface channel 10.Thereby tubular body 30 can radially compressiblely be convenient to for example use conduit or analog to approach and insert in interface channel 10, thereby and inflatable inner face or the inner side that closely engages interface channel wall construction 25 radially then, and can comprise the Cardiac valve prosthesis 40 (for example schematically showing) being arranged in tubular body 30 in Fig. 6 a.

(nature) chamber cardiac valve 5 (for example Bicuspid valve or Tricuspid valve) to be replaced has circle wall structure 25 substantially, described cardinal principle circle wall structure forms interface channel 10 between atrial chamber 15 and the ventricular chamber 20 of heart or pass through openings and comprises circumference lobe ring, at the close position open and close interface channel/pass through openings of lobe ring and the lobe leaf of closed interface channel 10/ pass through openings, be connected to lobe leaf and (one or more) the cardinal principle circumference cord structures (chordae tendineae) between circumference papillary muscles substantially, and described (one or more) papillary muscles.

Cardiac valve prosthesis 40 can be attached to tubular body 30 and can be designed to for example, artificial replacement's valve as chamber cardiac valve (Bicuspid valve and/or Tricuspid valve).Artificial valve 40 can comprise artificial lobe for the replacement of function of natural heart valve (for example,, as three lobes that schematically show in Fig. 6 a for example).Tubular body 30 can be with outer circumferential groove 45.Outer circumferential groove 45 can be opened wide to the radial outside of tubular body 30.Circumferential groove 45 can limit bottom portion of groove 46.Outer circumferential groove 45 can limit passage 47, and described passage self is limited by bottom portion of groove 46 and axial (on the axial direction of tubular body 30) opposing sidewalls 48,49.Bottom portion of groove 46 can be divided into tubular body 30 the first and second main part sections 31,32.Circumferential groove 45 can around the whole circumferential extension of tubular body 30 or can be only partly around the circumferential extension of tubular body 30.Outer circumferential groove 45 can be continuous, it is non-interruption groove, but can be also to interrupt groove 45, for example there are two or more circumferential groove parts 45 in the same axial level that is located at tubular body 30, it is interrupted by region, can provide the lands of groove part to be formed in described region.Circumferential groove 45 can have the certain axial distance (along axis 35) from the axial end of tubular body 30, that is, circumferential groove 45 can form with the end part compartment of terrain of tubular body 30 in the axial direction.

As shown in fig. 1, the first main part section 31 can be the part that is positioned at the tubular body 30 of (for example, at nearside) on circumferential groove 45, and the second main part section 32 can be the part that is positioned at the tubular body 30 in (for example, in distally) under circumferential groove 45.Both can have general cylindrical the first and second main part sections 31,32.According to modification, the first main part section 31 can have along the taper shape of the axis of tubular body, and its cross-sectional diameter increases from groove 45, and the second main part section 32 can be general cylindrical.According to modification, both can have the first and second main part sections 31,32 along the taper shape of the axis of tubular body, and their respective cross section diameter increases from groove 45.According to modification, the cross section of portion's section 31 and/or 32 (along axis 35) can be or comprise non-circular except ellipse or D shape cross section.In addition, the direction of the curvature in the axial profile (seeing in the axial cross section along tubular body 30) between groove 45 and the first main part section 31 and/or between groove 45 and the second main part section 32 can change (convex curvature that changes to the transition part between groove 45 and the first and/or second main part section 31,32 from the recessed curvature of groove 45).The axial opposing sidewalls 48,49 of groove 45 can be correspondingly a part for the first and second main part sections 31,32 and can correspondingly axially define first and second sections 31,32 towards the passage of groove 45 47, for example as shown in Figure 8.The radial diameter (for example, in the end office relative with the second main part section 32) of the first main part section 31 of tubular body 30 can be greater than any diameter of the second main part section 32.This can allow prosthese 1 to be fixed on more efficiently in interface channel 10, reason be there is the first main part section 31 of larger diameter can for example, by providing friction and/or (pure) form fit (be arranged in atrial chamber 15 by the first main part section 31 and diameter that the diameter that has is greater than interface channel 10 causes) that the better maintenance of prosthese 1 at interface channel 10 is provided.

In addition, valve prosthesis 1 can comprise more than first projection 50 and more than second projection 55.Projection 50,55 can correspondingly be extended from first and second sections 31,32 on contrary axial direction, that is to say that they for example, extend in the direction of the axis 35 along tubular body 30 (longitudinal axis 35), at least there is the component of extension or extend vector.Therefore, the first projection 50 and the second projection 55 are extended substantially towards each other, and they can not exclusively or be in line and extend towards each other thus, but have the vector of extension.The axis 35 that projection 50,55 can be roughly parallel to tubular body 30 extends or also can extend with 35 one-tenth, the axis of tubular body 30 (side direction) angle γ, the wherein tangent extension of circumference of (side direction) angle γ and tubular body 30, as example as shown in Figure 2 a.

Valve prosthesis 1 can comprise and can be on the axial direction of tubular body 30 extending and unique multiple projections 50,55 that can be overlapping with circumferential groove 45 from first or second section 31,32.For example, with reference to figure 11a-c, valve prosthesis 1 can not comprise that any projection 50,55 and circumferential groove 45 for example can be located at, on (, be integrally formed in) tubular body 30.

The projection of more than first projection 50 all can have free end 60, and the projection of more than second projection 55 all can have free end 65.The free end 60,65 of more than first and second projection 50,55 can be arranged to outer circumferential groove 45 overlapping.That is to say, overlapping with groove 45 thereby the free end of more than first and second projection 50,55 is arranged in the axial level place of groove 45.More than first and second projection 50,55 thereby can be along their extension at least in part or fully overlapping with groove 45.

The the one 50 and the 2 55 many projections can make radially (circumference) chamber 66 passage 47, be defined between bottom portion of groove 46 and more than first and second projection 50,55 from the extending radially outwardly of bottom 46 of groove 45 with certain radial distance.Opposing sidewalls 48,49 can also limit hollow chamber 66 on the axial direction of tubular body 30.Therefore, hollow chamber 66 can be radially by multiple projections 50,55 and bottom portion of groove 46 and axially for example, limited by the opposing sidewalls 48,49 (roof and diapire) of groove 45.

Use through the method for conduit valve prosthesis 1 and can comprise in the interface channel wall construction 25 that it is positioned to heart and then the tissue of the interface channel wall construction 25 of contiguous circumferential groove 45 be inserted in circumferential groove 45 to footpath to be placed on more than first and second projection 50,55 downwards.Organize then can by the 1 and/or more than second projection 55 in circumferential groove 45, be held in place, for example can be punctured in tissue with the described projection of sharp-pointed or sharpening end, described tissue can be got back to from its lower position bias voltage its initial radial position.The level of the lobe ring of the outer circumferential groove 45 that prosthese 1 can be located so that it in circle wall structure 25 or be adjacent towards the side of ventricular chamber 20.By more than first and second projections 50,55, tissue is remained in groove 45, can be with respect to heart location and fixing through conduit valve prosthesis 1.In addition,, because more than first and second projections 50,55 are axially extended towards each other, therefore also prevent safely and reliably that prosthese is axially pushed to outside interface channel 10 by the pumping effect of heart.The the one 50 and/or the 2 55 many projections can for example, for example, by piercing through its (pegs it, string it) and/or by interference engagement, the tissue of interface channel wall construction 25 being remained in circumferential groove 45.Remaining on can (partially or even wholly) the be connected interior face seal of path 10 of organizing also in circumferential groove 45 makes blood, for example blood that pressurizes can only flow through tubular body 30 (with Cardiac valve prosthesis 40 wherein) through conduit valve prosthesis 1, but can not (, between the outside of tubular body 30 and the inner face of interface channel wall construction 25) bypass pass through tubular body 30 in its outside.In this respect, the inner and/or outer circumferential surface of tubular body 30 can be additionally with the impermeable barrier of form that is for example liner 33b.

Prosthese 1 can be arranged in interface channel 10 and make circumferential groove 45 be positioned at the atrial side of the lobe ring of natural valve, for example, have with a certain distance from natural valve ring, that is, circumferential groove 45 can be that subring shape circumferential groove and/or prosthese 1 can be subring shape prostheses 1.Prosthese 1 can be well-suited for subring shape prosthese.That is to say, tubular body 30 can have be less than natural valve ring breadth wise dimension, in the axial breadth wise dimension (in this article also referred to as diameter) of level (with respect to axis 35), and/or the breadth wise dimension of tubular body and/or axial length can be applicable to making the first main part section 31 can be arranged in atrial chamber 15 and the second main part section 32 being positioned at the ventricular side of natural valve ring, have with a certain distance from described lobe ring.

Only a circumferential groove 45 as above can be located on tubular body 30.But, the microscler prosthese 1 with two or more circumferential grooves 45 can be provided, wherein corresponding in two or more grooves 45 can be arranged and distribute to the respective sets of more than first and second projections 50,55 as above.Groove 45 or corresponding recesses thereby can be formed by the first and second main part sections 31,32 of tubular body 30, wherein projection 50 and/or 55 thereby can not related to forming in (accordingly) groove 45.Also can have such embodiment (with further reference to below), wherein projection 50 and/or 55 forms groove 45 at least in part, for example, in a side of the tubular body 30 in adjacent heart chamber 20.

Tubular body 30 can comprise or can be the net type main body with the microscler net intersected with each other at intersection point 34 places or grating element 33.Mesh element 33 can for example, for example, by comprising steel and/or superalloy and/or marmem (Nitinol) and/or nickel and/or titanium and/or noble metal (gold) and/or comprising that the line of aforesaid alloy forms.Mesh element 33 also can comprise other alloy or can be by organic material, for example polymers manufacturing.Mesh element 33 for example can be by polrvinyl chloride and/or polystyrene and/or polypropylene or another kind of polymers manufacturing.Tubular body 30 can be manufactured by the shape-memory material expanding in the time being subject to normal body temperature.Tubular body 30 can be self-expanding.Tubular body 30 can not be also self-expanding, but can be expanded by sacculus or another kind of expansion mechanism.Correspondingly, tubular body 30 can be compressible can insert via conduit and then inflatable in the time suitably locating with interface channel wall construction 25.Tubular body 30 can comprise be attached to the mesh element 33 of manufacturing or being manufactured by different materials by same material above-mentioned liner 33b (referring to Fig. 6 a).Liner 33b can be arranged on the inner side of mesh element 33 and/or tubular body 30 or outside and can be on axial direction 35 and/or fully or only partly cover the circumference of tubular body 30 in a circumferential direction.

Thereby the circumferential groove 45 of tubular body 30 and/or first and/or the projection of more than second projection 50,55 can interact with respect to conduit wall structure 25 and interface channel 10 secure valve prostheses 1 with interface channel wall construction 25.The tissue of conduit wall structure 25 can " be captured " in circumferential groove 45 and by being held in place as the free end 60,65 of first and/or more than second projection 50,55 of hook element.The tissue of conduit wall structure 25 can pierce through and remain on more firmly thus in the circumferential groove 45 of tubular body 30 by free end 60,65, wherein organizes also and can remain in groove 45 by means of interference and/or clamping engagement between projection 50 and/or 55 (or its part) and the tissue of interface channel wall construction 25.For allow first and/or 50,55 punctures of more than second projection be pushed to the tissue of the circumference interface channel wall construction 25 in groove, multiple in the one 50 and/or the 2 55 many projections or the free end of each can be sharp-pointed or sharpening end.First and/or each of the projection of more than second projection 50,55 or wherein some can be pin.

With further reference to Fig. 1 b, thus first and/or the free end 60,65 of more than second projection 50,55 can be the tissue that conical end 70 can pierce through interface channel wall construction 25.According to modification, first and/or the free end 60,65 of more than second projection 50,55 can be also blunt.Free end 60,65 and/or first and/or more than second projection 50,55 can be pin-shaped.

Some or all in the free end 60,65 of projection 55,60 can comprise barb or the hook 71 as shown in Fig. 1 a.Hook 71 can be for piercing through the tissue of interface channel wall construction 25 and preventing the tissue free end 60,65 that slips away.Can not slide from free end 55,65 by being arranged in the tissue that barb on free end 60,65 or hook 71 pierce through thus, cause being trapped in more reliably in circumferential groove 45 from organizing of cardiac valve interface channel wall construction 25.Some or all in free end 60,65 can be blunt or can have conical end 70 or comprise barb or hook 71.The the one 50 or the 2 55 many projections can comprise dissimilar free end 60,65 according to anatomical condition, but also can comprise the free end 60,65 of same type.

Free end the 60,65 and/or the one 50 and the 2 55 many projections can relative to each other be arranged in disalignment to and/or radial position and orientation.With reference to figure 1 and 6a, each projection of more than first projection 50 can have identical angle of circumference distance alpha each other (angular distances between two radial direction of namely extending from the longitudinal axis 35 of tubular body 30),, projection 50 can be equally interval circumferentially.But the projection of more than first projection 50 also can have different angular distance alpha each other, that is, not around the interval, even circumferential ground of tubular body.Although do not show in Fig. 6 a-c, similarly, each projection of more than second projection 55 can have identical angular distance each other, that is, and and around the equally interval of circumference of tubular body 30.But the projection of more than second projection 55 also can have different angle of circumference distance alpha each other, that is, not around the interval, even circumferential ground of tubular body.

More than first projection 50 can be arranged in by this way and on tubular body 30, make each projection of more than first projection 50 haply for example, in the radial level identical with the projection of more than second projection 55 (namely identical radius, R2) upper (as shown in for example Fig. 1 and 3) with respect to more than second projection 55.On the other hand, each projection of more than first projection 50 can be arranged on the radius of the projection that is different from more than second projection 55, wherein more than first projection 50 all can be on identical radius, and wherein more than second projection 55 all can be on identical radius.

For example, with reference to figure 1 and 3, thereby more than first projection 50 and more than second projection 55 can be extended aligned with each other or coaxial.More than first projection 50 also can not aimed at more than second projection 55, and wherein more than first projection 50 can self roughly extend parallel to each other, may be not yet, and wherein more than second projection 55 can self roughly extend parallel to each other, and may not be also.

For example can arrange in an alternating manner in a circumferential direction with reference to figure 2 and more than 4, the first and second projection 50,55, wherein for example each the first projection 50 circumferentially between two the second projections 55 (vice versa).More than first and second projection 50,55 also can have other suitable circumference pattern, wherein for example, the group of the first projection 50 of for example, two, three, four or more the first projections 50 is arranged between the group of the second projection 50 of for example, two, three, four or more the second projections 50.

The quantity of the projection of the quantity of the projection of more than first projection 50 and more than second projection 55 for example can be three to five or eight to ten, 15 to 20,30 to 100 or more scope in, or can be any other quantity.More than first projection 50 can comprise the quantity of the projection identical from more than second projection 55 or the quantity of different projection, and vice versa.

The projection of the projection of more than first projection 50 and/or more than second projection 55 can be from tubular body 30, extend in intersection point 34 position intersected with each other from the mesh element 33 of tubular body 30.This can improve the mechanical stability of the interconnection of tubular body 30 and projection 50,55.Projection 50,55 for example can welding, soldering and/or is woven into tubular body 35.They also can sew up, bond or be glued to tubular body 35.As an alternative or additionally, projection 50,55 also can with tubular body 30 integrally entirety form.That is to say, for example, with reference to figure 9a and 9b, projection 50,55 (or any one or both) in multiple projection can be by not being connected to another mesh element 33 at intersection point 34 places but with respect to longitudinal axis 35 radially and/or on axial direction for example, from tubular body 30 outstanding (causing by bending mesh element 33) thus the mesh element 33 that forms projection 50,55 forms.In addition, projection 50,55 (for example form or provide individually and be connected with tubular body 30 by mesh element 33 is integrally overall) can be by radially and axially giving prominence to and form circumferential groove 45 from tubular body 30 with respect to longitudinal axis 35.Therefore,, by deviating from tubular body 30, projection can limit circumferential groove 45 on tubular body 30.Circumferential groove 45 also can for example, further be limited by cardinal principle cone shape or the similar shape of main part section (the first main part section 31 and/or the second main part section 32) of the tubular body 30 with the cross-sectional diameter increasing from groove 45 in the direction of longitudinal axis 35.Seen in for example Fig. 9 a and 9b, thereby therefore with from the outstanding projection 50,55 of tubular body 30 the cardinal principle cone shape of main part section 31,32 can interact and further limit circumferential groove 45.Fig. 9 a shows projection 50,55, and first described projection by giving prominence in general radial direction with respect to longitudinal axis 35 and then projecting upwards and limit circumferential groove 45 in the side that is roughly parallel to longitudinal axis 35 in the time that the point extending from tubular body 30 from projection is seen.Fig. 9 b shows projection 50,55, and described projection extends to limit circumferential groove 45 substantially point-blank.Projection 50,55 can be by the same material above with reference to described in tubular body 30, for example superalloy, for example marmem (such as Nitinol) or steel or the titanium alloy of titanium (or comprise) or such as the organic material manufacture of polymer, or projection can be manufactured by one or more different materials.

For example as seen from Figure 8, all or some projections of more than first projection 50 and/or all or some projections of more than second projection 55 can (along) roughly on straight line or extend on straight line,, they can not comprise the point that extends from tubular body 30 from them any longitudinal curvature to their corresponding free end 60,65,, they can extend point-blank.But they can comprise barb or hook 71 and/or can be pin-shaped.More than first projection 50 can be extended from tubular body 30 from roughly the same axial level (relevant to the axial direction of tubular body 30) (for example among Fig. 1 to 3, showing) or can be from the never coaxial horizontal-extending of tubular body 30.Correspondingly, more than second projection 55 can be extended from tubular body 30 from roughly the same axial level (relevant to the axial direction of tubular body 30) (for example among Fig. 1 to 3, showing) or can be from the never coaxial horizontal-extending of tubular body 30.The extending axially of more than first projection 50 and/or more than second projection 55 (axial distance (along the axis 35 of tubular body 30) between the base portion of the projection on tubular body and the free end of projection) can be roughly the same or can be different, and the extension of more than first projection 50 and/or more than second projection 55 or length (distance between the base portion of the projection 50,55 of tubular body 30 and the free end 60,65 of projection 50,55) can be identical or can be different.

Except more than first and second projections 50,55, tubular body 30 can be with the projection of any other type and/or the collar.

The the one 50 and the 2 55 many projections can be correspondingly from the one 31 and the 2 32 main part section from contiguous or extend in abutting connection with the region of the radially excircle of circumferential groove 45.The the one 50 and the 2 55 many projections can be extended from the opposing sidewalls 48,49 that laterally limits groove 45.

With reference to the free end 60 of more than 2, the first projection 50 of figure can be in the direction of the axis of tubular body 30 35 with the free end 65 of more than second projection 55 axially spacing shaft to distance W 2.The free end 60 of more than first projection 50 can be arranged in same axial level or disalignment in level, and the free end 65 of more than second projection 55 can be arranged in same axial level or disalignment in level.

Comprise unique multiple projection 50,55 through conduit valve prosthesis 1 in the situation that, axial distance W2 can limit one or more in the free end 60,65 of (unique) multiple projections 50,55 or all to the distance of multiple projections from the sidewall 48,49 of the relative circumferential groove 45 of the corresponding main part section 31,32 of its extension.

The projection of more than first projection 50 can with the projection of more than second projection 55 overlapping (not shown) axially each other, wherein can between the free end of more than first projection 50 60 and the free end 65 of more than second projection 55, limit axial overlap distance.Some free ends 60 of more than first projection 50 can with the axially interval of corresponding free end 65 of more than second projection 55, and that other free end 60 and 65 can be arranged to is axially overlapping each other.

For example, with reference to figure 2a, projection 50,55 (all) thus can extend in one way radially and angle of inclination beta upcountry, extend to obliquely thus in outer circumferential groove 45.Limiting projection 50,55 can be radially for example being equal to or less than 45 ° or be equal to or less than 30 ° or be equal to or less than the acute angle in the scope of 15 ° with intilted angle β with respect to the axis 35 of tubular body 30.An only part for the first projection 50 or an only part for some and/or the second projection 55 or some can radially and upcountry tilt as mentioned above.

The interaction (causing as the similar diagram in Fig. 6 a transverse to axis 35 and by the cross section of more than second projection 55) of the heart valve tissue of interface channel wall construction 25 and more than first projection 50 is shown corresponding to Fig. 6 a of the cross section along the A-A shown in Fig. 3.Can see that more than first projection 50 pierces through the tissue of interface channel wall construction 25, prevent more reliably that thus it from retracting from the tubular body 30 of prosthese 1, this causes prosthese 1 to remain on more firmly its desired location.

With further reference to Fig. 3 and Fig. 6 b, can also comprise microscler external component 75 through conduit chamber valve prosthesis 1.Microscler external component 75 can locate to be arranged at the axial level of the circumferential groove of tubular body 30 45 (for example, with respect to axis 35) outside (, for example, in ventricular chamber 20) of interface channel wall construction 25.Microscler external component 75 can be at least in part around, for example fully with contiguous circumferential extend and can for example use the duct element 90 schematically showing in Fig. 6 b to operate around tubular body 30.Thereby the radial distance R5 between longitudinal axis 35 and microscler external component 75 can reduce or reduce to make the valvular tissue of interface channel wall construction 25 to be correspondingly pushed to is at least in part positioned at more than first and second projection 50,55 at least in part footpath in outer circumferential groove 45 downwards.Radial distance R5 can reduce or reduce to make it to be less than the radial distance R4 (free end 60,65 is invisible in the cross section shown in Fig. 6 b, but they are indicated by the cross in Fig. 6 b) limiting between the longitudinal axis 35 of tubular body 30 and the free end 60,65 of projection 50,55.This means tissue that inside that microscler external component 75 can be positioned at the circumference being limited by more than first and second projections 50,55 makes interface channel wall construction 25 or can be in circumferential groove 45 between bottom portion of groove 46 and the first and second projections 50,55, wherein microscler external component 75 self can be in the inside of groove 45 between bottom portion of groove 46 and more than first and second projection 50,55.But microscler external component 75 also can be arranged to the tissue of interface channel wall construction 25 to be pushed in circumferential groove 45, still remain on the outside (that is, R5 can be greater than R4, as shown in Fig. 6 b) of groove.The pipe guide of duct element 90 or another for example similar structures can and be located microscler external component 75 for the outside operation around interface channel wall construction 25.

With further reference to Fig. 6 b and 7, duct element 90 can comprise connecting device 91, for example cutting and clamping device, described connecting device can be for connecting the free end of elongated elements 75 for example to cut microscler external component 75 and its two ends are clamped together, and makes elongated elements 75 can for good and all keep around tubular body 30 and form thus the parts of prosthese 1.But microscler external component 75 can be only also for example intervention tool as the parts of duct element, and can be only for organizing of interface channel wall construction 25 is radially pushed to outer groove 45, and then can retract or remove from heart.In the time that elongated elements 75 for good and all keeps locating around the outside of interface channel wall construction 25, it can for good and all will radially be applied to the tissue of interface channel wall construction 25 towards groove 45 with inside orientation force.

With reference to figure 1,3,6b and 7, can there be some modes that the heart tissue of interface channel wall construction 25 is fixed, kept and/or is trapped in circumferential groove 45.Tissue can be for example via sharp end 70 and/or barb or hook 71 by first and/or the free end 60,65 of more than second projection 50,55 pierce through.Organize also and can remain in circumferential groove 45 by the interference engagement between projection 50,55.Organize also and can be remained in circumferential groove 45 by microscler external component 75.Microscler external component 75 can be for temporarily (for example, as the method step during cardiac treatment) or for good and all (if for example in the time that microscler external component extends around the outside of interface channel wall construction 25 as shown in Figure 7 cutting and clamping device 91 for cutting microscler external component 75 and its two ends for good and all being linked together) tissue is pushed to groove 45.Organizing also of interface channel wall construction 25 can remain in circumferential groove 45 by two or more the combination in said apparatus and effect.

In all embodiments, the cross-sectional diameter D1 that microscler external component 75 can have a width W 1 (for example shown in Figure 2) that is less than outer circumferential groove 45 (for example referring to Fig. 6 b).Elongated elements 75 also can have the cross-sectional diameter D1 of the gap W2 between the free end 60,65 that is less than more than first and second projection 50,55.Elongated elements 75 can have the cross-sectional diameter D1 that is greater than width W 2, is still less than width W 1.Elongated elements 75 can have the cross-sectional diameter D1 that is greater than width W 2 and/or width W 1.Elongated elements 75 can be line or belt, and can have circular cross section or rectangular cross section.Elongated elements 75 also can have triangular cross section or limit the cross section of any other shape.Elongated elements 75 can be by combination or (one or more) other material manufacture about any material described in mesh element 33 or those materials.For example, elongated elements can be manufactured by steel, titanium alloy or marmem, for example Nitinol.

In addition, the length of projection 50 and/or 55 can be relevant to the width W of circumferential groove 45 1.In this respect, distance between the free end 60,65 of more than first and second projection 50,55 (or, if unique multiple projection 50,55 is provided, the free end 60,65 of the plurality of projection 50,55 is to the distance of the sidewall 48,49 about axis 35 circumferential groove 45 relative with projection 50,55) can there is 0.5 or 0.4 or 0.3 or 0.2 or 0.1 maximum with the ratio of the width W 1 of circumferential groove 45.Therefore hollow chamber 66 can be defined between projection 50,55 and bottom portion of groove 46.The width W 1 of circumferential groove 45 can be defined between the sidewall 48,49 of groove 45 and/or first and/or the point that extends from tubular body 30 of the projection 50,55 of more than second projection 50,55 and the sidewall 48,49 of the opposite side that is positioned at groove (45) between and/or the projection of more than first projection 50 from the point of its extension and the projection of more than second projection 55 between the point of its extension.

With reference to Figure 4 and 5 (for the ease of being aware and understand, be shown as and there is no artificial valve 40 through conduit valve prosthesis 1), also can comprise clamping element 80 through conduit valve prosthesis 1.Clamping element 80 can comprise the tubular structure with longitudinal axis, and described clamping element can be arranged in circumferential groove 45, extend on the circumferencial direction of tubular body 30.For example, thereby can being arranged in circumferential groove 45 (at least in part), clamping element 80 is positioned at the radially inner side of more than first and second projection 50,55.Clamping element 80 can contact with the bottom portion of groove of circumferential groove 45 46.Clamping element 80 can or only partly extend around tubular body 30 around the whole circumference of tubular body 30, as example as shown in Figures 4 and 5.Clamping element 80 can be for example extends around angle or any other angle of 10 to 30 degree in circumferential groove 45.Clamping element 80 also can be around the whole circumference of groove 45, for example, around 360 degree extensions.Clamping element 80 can have the cross-sectional diameter D2 transverse to its longitudinal axis.Cross-sectional diameter D2 can optionally can change to greater or lesser diameter D2,, clamping element 80 can for example, compressible (thereby can insert via conduit) in the radial direction of its diameter D2 and/or inflatable (compression after can expand) again, thus interior the and excircle of clamping element correspondingly tubular body 30 in the radial direction towards first and/or more than second projection 50,55 correspondingly reduce/expand and expand/reduce.The cross-sectional diameter D2 of clamping element 80 can be less than the cross-sectional diameter (for example showing radius R 1 in Fig. 6 a) of tubular body 30.Clamping element 80 can be provided to clamp the inside outside heart tissue on the direction from axis 35 towards multiple projections 50,55 that is positioned at circumferential groove 45.

With reference to figure 6d, clamping element 80 can be also or form the part of above-mentioned microscler external component 75, wherein clamping element 80 then can arrange and/or guide and/or locate (under radial compression) in the periphery of interface channel wall construction 25 completely or partially to extend around interface channel wall construction 25 at axial (with respect to the axis 35 of tubular body 30) level place, and then can radially expand (in the direction of the diameter D2 of clamping element 80), then correspondingly reduce at its diameter in the radial direction of tube element 30 thus, thus the tissue (then it be arranged in the inner side of clamping element 80) of the interface channel wall construction 25 of inwardly arranging is radially pushed in groove 45.That is to say, clamping element can be between projection 50,55 and the tissue of interface channel wall construction 25, and described tissue can put on the corresponding counteracting force that the elastic force of tissue of interface channel wall construction 25 and clamping element 80 put on projection 50,55 by clamping element 80 and be pressed in groove 45.The power of the tissue that acts on interface channel wall construction 25 that can for example, be applied by clamping element 80 and groove 45 (bottom portion of groove 46) is schematically indicated by arrow 85b.Microscler external component 75 and/or clamping element 80 (it can be similar elements) can be for anchoring prostheses 1 and against prosthese sealing nature heart valve leaflet in case Hemostatic Oral Liquid is mobile.In addition, for example, for example can be contributed to heart (for example lobe leaf) tissue ingrowth, to prosthese (circumferential groove 45) in and further be improved thus the sealing of fixing and/or prevent blood flow of prosthese 1 with respect to heart by the fixing nature lobe leaf of prosthese 1 (comprising clamping element 80 and/or elongated elements 75) as described herein, reason is that inside growing tissue can additionally or alternatively seal to prevent the blood flow on the outside of tubular body 30.

Fig. 6 c shows the schematic cross section of the tubular body 30 and the clamping element 80 that are similar to the cross section C-C in Fig. 4, but additionally shows the heart tissue of the interface channel wall construction 25 not showing in Fig. 4.In Fig. 6 c, first or the position of more than second projection 50,55 by round dot 50,55 instructions.Can see from Fig. 6 c, the heart tissue of interface channel wall construction 25 the inner radial of circumferential groove 45 the bottom portion of groove 46 of tubular body 30 and by first and/or the diameter that limits of the free end 60,65 of more than second projection 50,55 between.From Fig. 6 c can see clamping element 80 by the tissue elasticity crustal strain of interface channel wall construction 25 and then apply power, described power is pressed in the tissue of interface channel wall construction 25 on free end 60,65.Arrow 85 instruction power, described power is caused and is acted on the tissue of the interface channel wall construction 25 in groove 45 by clamping element 80.

For example, with reference to Fig. 6 c and the 6d that only show a clamping element 80, also can there be two or more clamping elements 80 that are for example arranged in groove 45, described clamping element can be arranged parallel to each other and/or sequentially arrange on the circumferencial direction of tubular body 30, for example, have circumferential distance or against each other therebetween.For example, can there be two clamping elements 80 against each other and have from the 3rd clamping element 80 of two clamping elements against each other, 80 certain angular distances and also can be arranged in groove 45.Clamping element 80 for example can be positioned at the diameter opposite side of groove 45.These two or more (for example 3 to 5) clamping element 80 can all have identical cross-sectional diameter D2 or can all have different cross-sectional diameters.Clamping element 80 can all have identical longitudinal length or can have different longitudinal length (for example, on the circumferencial direction of tubular body 30).Clamping element 80 can for example, according to the situation design of particular organization's structure of (patient's) specific heart and interface channel wall construction 25 and be arranged so that tubular body 30 is held in place securely.They for example can specifically be selected according to local conditions and be arranged that tubular body 30 is held in place securely by operator or surgeon.Corresponding clamping element 80 can have other shape except tubulose, for example block, cube or spherical.

The power that acts on the tissue of interface channel wall construction 25 in the time that clamping element 80 uses together with microscler external component 75 can increase, and further improves thus the connection between conduit valve prosthesis 1 and interface channel wall construction 25.In this case, the elastic force that is derived from clamping element 80 from axis 35 points to and inwardly point to the masterpiece that is derived from microscler external component 75 of axis 35 for the tissue of interface channel wall construction 25, is firmly held in prosthese 1 its desired location in interface channel 10 thus.But, valve prosthesis 1 can be in the situation that there is no clamping element 80 and microscler external component 75 yet (independent) use or only use with together with (any one) in them.For example, when microscler external component 75 and/or clamping element 80 are substantially when rigidity, for example, in the time comprising or be full of the inflatable balloon of material (rigidity causes by pressure or by the curing of this material) of giving its rigidity, do not comprise that the prosthese 1 of multiple projections 50,55 can be fixing by clamping element 80 and/or microscler external component 75.This material can be within the limited time, for example, by the injection of additive reagent (networking agent) or by applying heat or energy solidifies.It can be the blend of PMMA (polymethyl methacrylate), different epoxy resin, polyurethane, polyurethane silicones.It can for example, by adding fortifying fibre (Kevlar, carbon) to strengthen.

Clamping element 80 can and can comprise inner chamber by net structure manufacture as shown in Figures 4 and 5.Net can be by metal or organic material or other material manufacture.The net of clamping element 80 can for example be manufactured by the alloy of ferrum, nickel, aluminum and/or titanium and/or these metals and other element.Net can be for example for example, for example, by steel (spring steel) and/or superalloy and/or marmem (Nitinol), Ti6Al4V and/or noble metal, such as gold or those any combination and/or other material manufacture.The net of clamping element 80 also can be by polymer, for example manufactured by polypropylene or polrvinyl chloride, polyethylene or nylon.Certainly, net also can be manufactured by the combination of these materials, that is, it can be manufactured by two or more different materials.In one embodiment, clamping element can be with being coated with the steel of Dacron or ePTFE graft or expandable stent-graft that Nitinol support is manufactured.The net of clamping element also can or additionally comprise about the mesh element 33 of tubular body 30 and/or any material of describing about elongated elements 75, and clamping element 80 can be designed to and its material can be chosen to produce high resiliency power so that the tissue of interface channel wall construction 25 is pressed in projection 50,55.Clamping element 80 also can arrive the attached of tubular body 30 to produce with hook or barb.

Clamping element 80 and/or microscler external component 75 also can comprise inflatable interior element (not shown).Thereby inflatable interior element can be arranged in the inner chamber of clamping element 80 and can inflate the diameter D2 that increases clamping element 80, thus the tissue of interface channel wall construction 25 is pressed in (if clamping element 80 is arranged in hollow chamber 66, from inner side, if clamping element 80 initial placement are in the outside of interface channel wall construction 25, from outside) in projection 50,55.Interior element can be used pipeline and be inflated from external pressure source, for example syringe, fluid bottle or the fluid that is positioned at the outside pump of health by operator.Clamping element 80 can be also the tissue of interface channel wall construction 25 to be pressed in to the inflatable element 80 in projection 55,55 in the time of inflation.Inflatable interior element and inflatable element 80 both can by thoroughly fluid, pressure-resistant material, for example, as above about the material as described in clamping element 80 or polymer or any other suitable material manufacture.For example, with reference to Figure 11, inflatable element can comprise aperture 76 (for example valve, for example opening), material (for example, via carrier pipe (not shown)) can be transported in inflatable element or be transported to outside inflatable element by described aperture.Aperture 76 can optionally allow the transmission (, having " open mode ") of material or can stop the transmission (, having " closure state ") of material.Aperture 76 can for example, for filling inflatable element or not filling (emptying) inflatable element to change the cross-sectional diameter of inflatable element.Clamping element 80 and/or microscler external component 75 can for example, be manufactured and/or can be filled with compressible (for example elasticity) material (for example gas and/or foamed materials and/or hydrogel) so that damping/pooling feature to be provided by elastomeric material (polymer and/or metal).Can be gas, liquid or any other material and/or can be the material (material for example can become cardinal principle solid phase from liquid phase) of the phase (for example gas phase, liquid phase, solid phase) that changes it when in inflatable element for the material of filling inflatable element.Thereby material can be in the time being arranged in inflatable element, can solidify and/or harden to provide the material of cardinal principle rigidity clamping element 80 and/or microscler external component 75.

For example, in the time of longitudinal axis expanded radially with respect to it, clamping element 80 can be applied to power the opposing sidewalls 48,49 of groove 45.This power can increase or reduce the distance between the axial end (with respect to axis 35) of distance between main part section 31 and 32 and/or tubular body 30.Tubular body 30 can be manufactured with elasticity (for example comprising web frame and/or elastomeric material).The power being applied by clamping element 80 also can correspondingly cause along the expansion of the girth of the bottom portion of groove 46 of the circumference of groove 45 or reduce and/or cause the tubular body 30 that the axial height (with respect to axis 35) of groove 45 locates diameter R1 expansion or reduce.Clamping element 80 and/or microscler external component 75 (it can be similar elements or can be independent component) can be not yet radial direction and/or tubular body 30 with respect to the longitudinal direction of its longitudinal axis 35 on generation power.Therefore, clamping element 80 and/or microscler external component 75 can be used as shift component by the tissue of the interface channel 10 that is shifted in the situation that clamping force not being applied to tubular body 30, but as for example organizing by the additional of the projection puncture of the one 50 or the 2 55 many projections or substituting, only provide the interference engagement between circle wall structure 25, clamping element 80 and/or the tubular body 30 of interface channel 10.

Thereby clamping element 80 and/or microscler external component 75 can only be positioned partially at the one 50 and/or the radially inner side of the 2 55 many projections and can be positioned to be kept with respect to tubular body 30 by arbitrary or two multiple projections punctures.Microscler external component 75 and/or clamping element 80 can be by unique multiple projections 50,55 punctures and another multiple projections microscler external components 75 of clamping element 80/ (or, only comprise unique multiple projection (in a side of groove 45) another multiple projections can be provided at prosthese 1) that can not puncture.Multiple projections 50 and/or 55 clamping element 80 that can puncture makes the corresponding free end 60,65 of projection 50,55 end at the inside of clamping element 80 or the free end 60,65 of complementary protuberance 50,55 is penetrated by clamping element 80 and from clamping element to leave and make corresponding free end 60,65 can be positioned at the outside of clamping element 80.

With reference to figure 10b, the radially inner side that microscler external component 75 and/or clamping element 80 also can be located at projection 50,55 in groove 45 makes microscler external component 75 and/or clamping element 80 can't help projection 50,55 punctures.Microscler external component 75/ clamping element 80 can only keep (for example, in the time inflating, for example, in the time expanding) by the interference engagement between the projection 50,55 in tissue and/or the groove 45 of groove 45, interface channel wall construction 25 or friction/interference engagement.In addition,, as shown in Figure 10 b schematically, microscler external component 75/ clamping element 80 can have for the shape of cross section of substantially elliptical or have any other shape, for example triangle, rectangle or polygon.The substantially elliptical of microscler external component 75/ clamping element 80 shown in Figure 10 b can be caused by the design of microscler external component 75/ clamping element 80, for example when it with there is substantially elliptical tubular structure time expanding (for example when), or it can be caused by the anisotropy power that acts on microscler external component 75/ clamping element 80, described power is for example caused by tissue and/or the groove 45 of projection 50,55, circle wall structure 25.That is to say, microscler external component 75/ clamping element 80 can have roughly sphering cross section and in the time implanting (and for example expanding), can be difformity (for example oval) in the time not having External Force Acting thereon.

With reference to figure 10c, inflatable and/or can reduce diameter D2 that microscler external component 75 (for example clamping element 80) can have a width W 1 that is greater than circumferential groove 45 in the time expanding make microscler external component 75 can extend to outside groove 45 and can occupy circle wall structure 25 and the tissue of the formation chambers of the heart (for example ventricular chamber 20 and/or atrial chamber 15) between space, , microscler external component 75 for example, can form the shape that is arranged in for example, between interface channel wall construction 25 and the tissue/muscle of (ventricular chamber 20) chambers of the heart wall (for example butt) in the time expanding (complete expansion).Therefore, microscler external component 75 can be positioned at (for example partly, a for example part wherein) radially outer (with respect to axis 35) of circumferential groove 45 and 35 one or two main part sections 31,32 along tubular body 30 (for example, along the second main part section 32) that can parallel to the axis extend, be positioned at the radially outer of (for example partly, a for example part for microscler external component 75) groove (45) simultaneously.Therefore, elongated elements 75 can comprise dihedral (for example roughly describing the angle of about 90 °) cross section, it has and can substantially radially extend to the first angulation shank 75a in groove 45 with respect to axis 35, and the axis 35 that can be in substantially parallel relationship to tubular body 30 the second angulation shank 75b that (for example, along the first main part section 31 and/or the second main part section 32) extends on the outside of tubular body 30.That is to say, microscler external component 75 (for example the second angulation shank 75b) wherein can be arranged in the one 31 and/or the 2 32 main part section and form between the tissue/muscle of wall of the chambers of the heart, for example ventricular chamber 20 and/or atrial chamber 15.Although only the side at prosthese 1 shows microscler external component 75/ clamping element 80 in Figure 10 a-c, it also completely or partially (as shown in for example Figure 11 a-d) for example, extend around prosthese 1 (circumferential groove 45).Microscler external component 75/ clamping element 80 can be included in the free end 77,78 (for example two free ends 77,78) in the direction of central longitudinal axis, and described free end can not connect and/or be not against each other, that is, be spaced apart from each other.Free end 77,78 can have by being for example less than 180 ° with respect to axis 35, be less than 90 °, be less than 45 ° or be less than the angular distance each other (for example, in groove 45, for example, in the time inflating) that the angle of 10 ° limits in groove 45.Aperture 76 can be located in these free ends 77,78 or aperture 76 can be located in each of free end 77,78.When microscler external component 75/ clamping element 80 is only partly when circumferential groove 45 extends and therefore comprise free end, it can have the rigidity by material, for example being caused by curing material (it can solidify).

Therefore, the microscler external component 75 of clamping element 80/ (for example, in the time that it comprises for example elasticity as above and/or compressible material) can for example, further improve prosthese 1 fixing with respect to heart for the motion (being caused by heart beating, for example pulse) of the damping by for example, for example, as between heart (chambers of the heart) and prosthese 1 (tubular body 30) and/or buffer element damping heart to reduce acting on by heart beating the power that prosthese 1 causes by these power of damping.Therefore, the microscler external component 75 of clamping element 80/ can absorb ((for example papillary muscles of ventricular chamber 20) of for example ventricle wall) and moves to avoid the pulsation of prosthese 1.Clamping element 80 can for example, for keeping the distance of the centrifugal dirty tissue of prosthese 1 (tissue of centrifugal chamber 20 and/or atrial chamber 15) and improving thus the placement of prosthese 1 and/or fix.Therefore, microscler external component 75 and/or clamping element 80 can be used as damping element and/or spacer element.When have the natural valve ring observation of certain distance from polypetalous ring, clamping element 80 and/or microscler external component 75 and therefore groove 45 can be arranged in ventricular chamber one side.

The shape of for example, cross section on its longitudinal axis (axis 35) of tubular body 30 can be modified.Duct element 90 can comprise or provide lancet and means, and described lancet and means can be positioned at respect to the axial roughly diagonal position of (with respect to axis 35) cross section for example, by interface channel wall construction 25 outside of interface channel wall construction 25 (from) with by tubular body 30.Lancet and means can be hollow and allow anchor to be placed on the distal position with respect to the diameter of the interface channel wall construction 25 of duct element 90 on interface channel wall construction 25.Described anchor can be attached to longitudinal end of longitudinal component (for example tether), and described longitudinal component again can be at its another longitudinal end with the second anchor.In the time that the near-end (with respect to duct element 90) of the described diameter of lancet and means on interface channel wall construction 25 is retracted from interface channel wall construction 25, the second anchor can be placed by lancet and means.The length of described longitudinal component can be designed to be subject to the tension force from the caused power that acts on longitudinal component of the first and second anchors, thereby produce tubular body 30 and be deformed into substantially elliptical, for example in the time there is no External Force Acting in tubular body 30, longitudinal component can be shorter than the diameter of tubular body 30.The position that the inner chamber that longitudinal component can cross tubular body 30 is placed on it does not disturb the function of valve 40, for example, geometrically spaced apart with valve 40.It also can be enough little obviously disturbs by the blood flow of tubular body 30 avoiding, for example, can have at 100 μ m to radius or diameter in the scope of 1000 μ m.

Can comprise that through all embodiment of conduit valve prosthesis 1 location and/or orienting device are so that the relative and/or absolute fix of tubular body 30 and/or microscler external component 75 and/or clamping element 80.These devices can comprise the passive marker that is attached to regularly tubular body 30 and/or microscler external component 75 and/or clamping element 80.Passive marker can be by the material manufacture different from the material of tubular body 30 and/or microscler external component 75 and/or clamping element 80 to be for example being used magnetic resonance or the imaging technique based on X ray to carry out improving contrast during medical imaging.Passive marker for example can be by height radiopaque material manufacture, allow thus accurately to obtain through the parts of conduit valve prosthesis 1 with respect to health relatively and/or absolute position.Passive marker all can have that thereby asymmetric shape allows identification definitely and/or relative position and orientation and identify thus tubular body 30 and/or position and the orientation of microscler external component 75 and/or clamping element 80.Passive marker also can have same shape and can relative to each other be orientated to allow to identify with certain deployment arrangements.The circumferential groove 45 of tubular body 30 and/or tubular body 30 and/or microscler external component 75 and/or clamping element 80 can have attached so that use imaging technique passive marker that they are relative to each other located regularly, for example for example, in the time of the imaging technique (x-ray imaging) of use based on electromagnetic radiation by the passive marker of height radiopaque material manufacture.In addition and/or as an alternative, the other parts/parts of circumferential groove 45 and/or tubular body 30 and/or microscler external component 75 and/or clamping element 80 can be by radiopaque material manufacture.

Use the method through conduit prosthese 1 as above to comprise:

Via inserting conduit by being placed in the chamber valve of human or animal's heart through conduit valve prosthesis 1, in for example Bicuspid valve or Tricuspid valve.For example can be placed in the interface channel wall construction 25 between ventricular chamber 20 and atrial chamber 15, as shown in fig. 1 through conduit valve prosthesis 1.

In order to be placed in cardiac valve through conduit valve prosthesis 1, can apply following route: 1) via the retrograde route of the tremulous pulse that enters the chambers of the heart on aorta, 2) by venous channel with by the puncture (transseptal approach) through interatrial septum, 3) via the puncture by the apex of the heart (through apex of the heart route), 4) via the outside from heart by the puncture of atrial walls, 5) arterial passageway (for example, by the femoral artery of the puncture in groin) or 6) any other route well known by persons skilled in the art.Route to valve is promoted, and reason is that tubular body 30 is radially compressible and inflatable and for example can be during route folded and be packed in conduit and when can launch extension in the time that circumference interface channel wall construction 25 is interior.Through conduit valve prosthesis 1 can comprise clamping element 80 or in the time that tubular body 30 is arranged in interface channel wall construction 25 clamping element 80 can insert independently via the one of described route (for example using conduit) thereby be placed on the circumferential groove 45 of tubular body 30.Clamping element 80 can be compressible and inflatable.

To be fixed in heart through conduit valve prosthesis 1 with respect to valve.

For valvular replacement of function, fix and seal to prevent the blood flow on the outside of conduit valve prosthesis 1 in interface channel wall construction 25 with respect to interface channel wall construction 25 through conduit valve prosthesis 1.For this reason, the inside that the tissue of the interface channel wall construction 25 of contiguous circumferential groove 45 could be pushed or be placed on circumferential groove 45 be bonded on the 1 and the footpath of the 2 55 many projections downwards, prevent that by the one 50 and/or the 2 55 many projections tissue from sliding into outside groove 45 thus, wherein the one 50 and/or the free end 60,65 of the 2 55 many projections tissue that can puncture.The tissue of interface channel wall construction 25 can be pierced through or for example partly be pierced through by projection 50,55 (fully), and thus can anti-skidding outside circumferential groove 45.Clamping element 80 or two or more clamping elements 80 can be located in circumferential groove 45 organizing of interface channel wall construction 25 is pressed on one's own initiative on free end 60,65 so that tissue and free end 60,65 interlockings.This causes being held in place more firmly and sealing to prevent the blood flow between outside and the interface channel wall construction 25 of tubular body 30 through conduit valve prosthesis 1.

For tissue being placed in the circumferential groove 45 of tubular body 30, use through the method for conduit valve prosthesis 1 and can comprise and use microscler external component 75 organizing radially and being upcountry pushed in circumferential groove 45 (it can comprise or not comprise clamping element 80) interface channel wall construction 25.With reference to figure 3, microscler external component 75 can be arranged on the outside of interface channel wall construction 25 at the level place of circumferential groove 45.Then, with reference to figure 6b, the distance R 5 between microscler external component 75 and the axis 35 of tubular body reduces (this means that the distance between bottom 46 and the microscler external component 75 of circumferential groove 45 of tubular body 30 also reduces) thereby the tissue of interface channel wall construction 25 is pushed in circumferential groove 45 so that tissue is fixed in circumferential groove 45.Microscler external component 75 can operate and can be used to microscler external component 75 is taken to near of interface channel wall construction 25 as the route about through as described in conduit valve prosthesis 1 or any other route via duct element 90.When the tissue of interface channel wall construction 25 is by projection 50, 55 while remaining in circumferential groove 45, elongated elements 75 (with duct element 90) can be removed from heart, or schematically shown in Figure 7, can use the connecting device 91 of duct element 90 to two (freedom) end of microscler external component 75 is for good and all linked together and cut end for good and all remains in the level of circumferential groove 45 of tubular body 30 microscler external component 75 on the outside of interface channel wall construction 25, thereby organizing of interface channel wall construction 25 additionally remained in circumferential groove 45.

Use and can cause being fixed to interface channel wall construction 25 and being held in place via organizing securely through conduit valve prosthesis 1 through the method for conduit chamber prosthese 1, described tissue is remained in circumferential groove 45 by free end 60,65, is supported alternatively by the microscler external component 75 of clamping element 80 and/or permanent arrangement.

The expression that (description and/or accompanying drawing and/or claim) is described in this article comprise the feature through conduit chamber valve prosthesis 1 through conduit chamber valve prosthesis 1 of the one 50 and the 2 55 many projections and the method step that relates to prosthese be also applicable to comprise unique multiple projection (50,55) through conduit chamber valve prosthesis 1, vice versa.Especially, the feature of describing the projection further to limit more than first and second projection in the application's (description, claim, accompanying drawing) is also applicable to only more than first projection, if valve prosthesis only comprises more than first projection (being exactly like this in claim 1).All features are herein disclosed as between all embodiment through conduit chamber valve prosthesis 1 interchangeable.

Claims

The valvular replacement of function of chamber of the interface channel (10) between the atrial chamber for heart (15) and ventricular chamber (20) through conduit chamber valve prosthesis (1), described interface channel has circumference interface channel wall construction (25), describedly comprises through conduit chamber valve prosthesis:

Radially expandable tubular main body (30), described radially expandable tubular main body will be arranged in the inside of described interface channel (10) and extend along axis (35), and

Valve (40), described valve is arranged in described tubular body (30) and is attached to described tubular body, wherein

Described tubular body (30) is with outer circumferential groove (45), bottom portion of groove (46) is opened wide and limited to described outer circumferential groove to the radial outside of described tubular body (30), described tubular body (30) is divided into the first (31) and second (32) main part section by described outer circumferential groove thus, and wherein

Described tubular body (30) is with more than first projection (50,55), described more than first projection extended and each of described more than first projection has and is arranged to the free end overlapping with described outer circumferential groove (45) (60,65) from the described first or second main part section (31,32) on the axial direction of described tubular body (30)

Also comprise microscler external component (75), described microscler external component will be arranged at the level place of described circumferential groove (45) on the outside of described interface channel wall construction (25), wherein said microscler external component (75) can extend around described tubular body (30) at least in part, the valvular tissue of described interface channel wall construction (25) be correspondingly arranged in circumferentially between described tubular body (30) and described external component (75) and from the described axis (35) of described tubular body (30) have that valvular tissue that such radial distance (R5) makes described interface channel wall construction (25) can radially be pushed to described outer circumferential groove (45) thus in be positioned at least in part described projection (50, 55) footpath downwards.
2. according to claim 1 through conduit chamber valve prosthesis (1), wherein said the first main part section (31) is suitable for being arranged in atrial chamber (15) one sides in described interface channel (10) and described the second main part section (32) is suitable in described interface channel (10), arranging ventricular chamber (20) one sides, and wherein said more than first projection (50) extended from described the second main part section (32).
3. according to claim 1 and 2 through conduit chamber valve prosthesis (1), wherein said microscler external component (75) thus comprise that the tubular structure with central longitudinal axis extends in described circumferential groove (45) on the circumferencial direction of described tubular body (30), wherein said microscler external component (75) has the cross-sectional diameter (D2) transverse to its central longitudinal axis, and wherein said cross-sectional diameter (D2) is greater than alternatively 2mm and/or is less than alternatively 15mm.
4. according to chamber valve prosthesis in any one of the preceding claims wherein (1), wherein said microscler external component (75) is formed or is comprised inflatable element by inflatable element (75), thereby described inflatable element is suitable for inflating by material the described microscler external component (75) that expands.
According in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said microscler external component (75) is provided as the inflatable and/or compressible in the radial direction of cross-sectional diameter (D2) at it.
6. chamber valve prosthesis according to claim 4 (1), wherein said material is curable materials, described curable materials be suitable in described inflatable element (75) thus in solidify and give described microscler external component (75) rigidity.
7. according to chamber valve prosthesis in any one of the preceding claims wherein (1), wherein said microscler external component (75) partly around described tubular body (30), alternatively with at least 180 ° or at least 270 ° of extensions, and there is interval and non-butt free end.
8. according to chamber valve prosthesis in any one of the preceding claims wherein (1), wherein said microscler external component (75) is manufactured by net structure.
According in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said tubular body (30) comprises having the net type main body of locating microscler mesh element (33) intersected with each other at intersection point (34), wherein said multiple projections (50,55) and integrally entirety formation of described tubular body (30).
According in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), be wherein greater than any diameter in the described second main part section (31) in the radial direction of axis (35) at the diameter of the described first main part section (31) in the radial direction of axis (35).
11. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein

Described tubular body (30) is with first (50) and second (55) multiple projections of correspondingly extending from described the first and second main part sections (31,32) in the opposite shaft orientation direction at described tubular body (30), and each of described more than first and second projections has and is arranged to the free end overlapping with described outer circumferential groove (45) (60,65).
12. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said first (50) and/or second (55) multiple projections are all provided with rectilinear form.
13. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said first (50) and/or second (55) multiple projections correspondingly from described first (31) and second (32) main part section extend, have from described bottom portion of groove (46) thus radial distance limit the hollow chamber (66) between described projection (50,55) and described bottom portion of groove (46).
14. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said first (50) and/or second (55) multiple projections in the region of the radially excircle of contiguous described outer circumferential groove (45) correspondingly from described the first (31) and second (32) main part section extension.
15. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), described axis (35) angulation (β) of wherein said first (50) and/or second (55) multiple projections and described tubular body (30) extends radially inwardly in described outer circumferential groove (45), and wherein said angle (β) can be equal to or less than 45 ° or be equal to or less than 30 ° or be equal to or less than 15 °.
16. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said projection (50,55) is roughly extended in the plane of described axis that comprises described tubular body (30).
17. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein the free end of multiple described first (50) and/or second (55) multiple projections (60,65) is sharp-pointed and/or sharpening end.
18. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein the free end of multiple described first (50) and/or second (55) multiple projections (60,65) is with barb or hook (71).
19. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said tubular body (30) comprises or has the net type main body of locating microscler mesh element (33) intersected with each other at intersection point (34), and wherein said projection (50,55) is extended from the intersection point (34) of contiguous described outer circumferential groove (45).
20. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein in the time observing in the axial cross section along described tubular body (30), curvature in axial profile between described groove (45) and described the first main part section (31) and/or between described groove (45) and described the second main part section (32) or bending direction change to described groove (45) and the described first and/or second main part section (31 from the recessed curvature of described groove (45), 32) convex curvature at the transition part place between.
21. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said microscler external component (75) comprises one or more clamping elements (80) or is formed by one or more clamping elements, each clamping element comprises that tubulose clamps element body, described tubulose clamp that element body extends on the circumferencial direction of described tubular body (30) along axis and with respect to described clamping element (80) thus axis radially inflatable described circumference interface channel wall construction (25) is organized in to being forced inwardly in the radial direction in described outer circumferential groove (45) of described tubular body (30).
22. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), it also comprises and will in described circumferential groove (45), be arranged in described first and/or more than second projection (50, 55) footpath one or more clamping elements (80) downwards, the valvular tissue of described interface channel wall construction (25) described first and/or more than second projection and corresponding clamping element (80) between, wherein radial clamping power (85) is put on described bottom portion of groove (46) and valvular tissue by corresponding clamping element (80), thereby radially promote valvular tissue towards described bottom portion of groove (46).
23. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said is to be suitable for the subring shape anchoring prosthese implanted through conduit chamber valve prosthesis (1), and described circumferential groove (45) is positioned at ventricular chamber (20) one sides of valvular valve annulus and described circumferential groove (45) and has the certain distance of polypetalous zona.
24. according in any one of the preceding claims wherein through conduit chamber valve prosthesis (1), wherein said microscler external component (75) comprises the angular cross section with the first angulation shank (75a) and the second angulation shank (75b), described the first angulation shank radially extends in described circumferential groove (45) substantially with respect to axis (35), the axis (35) that described the second angulation shank is in substantially parallel relationship to described tubular body (30) at described tubular body (30) thus outside on extend and be arranged between the described second main part section (32) and the ventricular chamber wall of heart of described tubular body (30).
25. 1 kinds for implanting the method through conduit chamber valve prosthesis (1), describedly comprise tubular body (30) and microscler external component (75) through conduit chamber valve prosthesis, described tubular body has longitudinal axis (35), circumferential groove (45) and multiple projection (50,55), each projection has and is arranged to overlapping with described groove (45) at least in part free end (60,65), said method comprising the steps of: the inside that described tubular body (30) is positioned to the interface channel (10) between atrial chamber (15) and the ventricular chamber (20) of heart, described microscler external component (75) is positioned on the outside of described interface channel at the axial level place of described circumferential groove, and by reduce distance (R5) between described microscler external component (75) and described tubular body (30) make the tissue of described interface channel insert described groove (45) thus in respect to described axis (35) at least in part in described projection (50,55) inner radial and with respect to the fixing described prosthese (1) of heart.
26. is according to claim 25 for implanting the method through conduit chamber valve prosthesis (1), it also comprises described tubular body (30) is located to the mitral lobe ring of the contiguous nature of described groove (45) locates towards ventricular chamber (20), make in the time that described microscler external component (75) inserts in described groove (45), in described groove (45), realize the anchoring of subring shape prosthese by described microscler external component (75) is bonded on.
27. according to the method described in claim 25 or 26, and the step of wherein locating described tubular body (30) comprises the retrograde route of use tremulous pulse and/or uses venous channel and enter the chambers of the heart by the puncture of interatrial septum and/or by puncture through apex of the heart route and/or from the outside of heart via the apex of the heart puncture use atrial walls and/or use by the femoral artery path of the puncture groin.
28. according to the method described in any one in claim 25 to 27, wherein said microscler external component (75) comprises cross-sectional diameter (D2), and the step of wherein fixing described prosthese (1) comprise change the cross-sectional diameter (D2) of described microscler external component (75) thus reduce described microscler external component (75) and described tubular body (30) between radial distance (R5).
29. methods according to claim 28, wherein said microscler external component (75) is formed by inflatable element or comprises inflatable element, and the cross-sectional diameter (D2) that wherein changes described microscler external component (75) is included as described inflatable element inflation.
30. methods according to claim 29, wherein realize and inflating by curable materials being inserted in described inflatable element, and wherein said curable materials solidify under the inflated condition of described inflatable element.
31. according to the method described in any one in claim 25 to 30, wherein said prosthese (1) comprises multiple projections (50,55), and the step of wherein fixing described prosthese (1) comprises at least part of radially inner side that with respect to axis (35), described microscler external component (75) is placed on to described projection (50,55), and comprise alternatively with described multiple projections (50,55) described microscler external component (75) that punctures, described microscler external component (75) is kept by described multiple projections (50,55).